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A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes

NCT06542874

CompletedPhase 2

Sponsor: Novo Nordisk A/S

Conditions: Type 2 Diabetes (T2D)

Interventions: NNC0487-0111 subcutanous, Placebo (NNC0487-0111 subcutanous), NNC0487-0111 oral, Placebo (NNC0487-0111 oral)

Countries: United States, Bulgaria, Croatia, Germany, Greece, Hungary, Japan, Poland

The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo. Which treatment the participant get is decided by chance.The study will last for about 43 weeks.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Male or female, aged 18-75 years (both inclusive) at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus greater or equal to 180 days before screening.
* Stable daily dose(s) greater or equal to 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without SGLT2 inhibitor.
* HbA1c of 7.0-10.0 procent (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.
* Body mass index between greater or equal to 23.0 and below 50.0 kg/m\^2.
* Able and willing to adhere to the protocol including wearing a continuous glucose monitoring (CGM) device provided for the study, as judged by the investigator.

Exclusion Criteria:

* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
* Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.

Locations (137)

Birmingham, Alabama, United States
Los Angeles, California, United States
Santa Ana, California, United States
Waterbury, Connecticut, United States
Fleming Island, Florida, United States
Hollywood, Florida, United States
Miramar, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Chicago, Illinois, United States
Topeka, Kansas, United States
Paducah, Kentucky, United States
Hyattsville, Maryland, United States
Oxon Hill, Maryland, United States
Boston, Massachusetts, United States
Methuen, Massachusetts, United States
Troy, Michigan, United States
Troy, Michigan, United States
Chesterfield, Missouri, United States
City of Saint Peters, Missouri, United States
Albany, New York, United States
Morehead City, North Carolina, United States
Statesville, North Carolina, United States
Fargo, North Dakota, United States
Fargo, North Dakota, United States
Norman, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Rapid City, South Dakota, United States
Kingsport, Tennessee, United States
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